What Should IRBs Consider When Reviewing A Protocol in Which Race - - PDF document

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What Should IRBs Consider When Reviewing A Protocol in Which Race Will Be Identified?

Heather M. Butts, J.D., M.P.H. Heather M. Butts, J.D., M.P.H. Ruth L. Fischbach. Ph.D., M.P.E. Ruth L. Fischbach. Ph.D., M.P.E.

EGIR Conference EGIR Conference May 19, 2006 May 19, 2006

Definition of Race: Genetics

“ “An inherent biological characteristic that An inherent biological characteristic that accurately reflects human ancestry and accurately reflects human ancestry and the flow of common threads of genetic the flow of common threads of genetic material in biologically distinct populations material in biologically distinct populations

• ver time and geography.
• ver time and geography.”

”

(Fine et al. The role of race and genetics in health (Fine et al. The role of race and genetics in health disparities research, disparities research, American Journal of Public Health American Journal of Public Health, , 2125 2125-

• 2128, December 2005).

2128, December 2005).

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Definition of Race/Minority Group Definition of Race/Minority Group Used by the NIH Used by the NIH

“ “A minority group is a readily identifiable A minority group is a readily identifiable subset of the U.S. population that is subset of the U.S. population that is distinguished by distinguished by racial racial, ethnic, and/or , ethnic, and/or cultural heritage. cultural heritage.” ”

NIH Policy and Guidelines on The Inclusion of Women and Minoriti NIH Policy and Guidelines on The Inclusion of Women and Minorities as es as Subjects in Clinical Research Subjects in Clinical Research – – Amended, October, 2001. Amended, October, 2001. http://grants.nih.gov/grants/funding/women_min/guidelines_amende http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2 d_10_2 001.htm 001.htm

Racial Designations from NIH

Hispanic or Latino -

• a person of Cuban, Mexican, Puerto Rican, South

a person of Cuban, Mexican, Puerto Rican, South

• r Central American, or other Spanish culture or origin, regardl
• r Central American, or other Spanish culture or origin, regardless of

ess of

• race. The term "Spanish origin" can also be used in addition to
• race. The term "Spanish origin" can also be used in addition to "Hispanic

"Hispanic

• r Latino."
• r Latino."

Not Hispanic or Latino Not Hispanic or Latino

The following definitions apply for racial categories. .

American Indian or Alaska Native American Indian or Alaska Native -

• a person having origins in any of

a person having origins in any of the original peoples of North, Central, or South America, and wh the original peoples of North, Central, or South America, and who

• maintains tribal affiliations or community attachment.

maintains tribal affiliations or community attachment. Asian Asian -

• a person having origins in any of the original peoples of the F

a person having origins in any of the original peoples of the Far ar East, Southeast Asia, or the Indian subcontinent including, for East, Southeast Asia, or the Indian subcontinent including, for example, example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals fr Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the

• m the

Philippine Islands have been recorded as Pacific Islanders in pr Philippine Islands have been recorded as Pacific Islanders in previous evious data collection strategies.) data collection strategies.)

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Racial Designations from NIH Racial Designations from NIH continued continued

Black or African American Black or African American -

• a person having origins in

a person having origins in any of the black racial groups of Africa. Terms such as any of the black racial groups of Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or "Haitian" or "Negro" can be used in addition to "Black or African American." African American." Native Hawaiian or Other Pacific Islander Native Hawaiian or Other Pacific Islander -

• a person

a person having origins in any of the original peoples of Hawaii, having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands. Guam, Samoa, or other Pacific Islands. White White -

• a person having origins in any of the original

a person having origins in any of the original peoples of Europe, the Middle East, or North Africa. peoples of Europe, the Middle East, or North Africa.

NIH Policy and Guidelines on The Inclusion of Women and Minoriti NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in es as Subjects in Clinical Research Clinical Research – – Amended, October, 2001. Amended, October, 2001. http://grants.nih.gov/grants/funding/women__min/guidelines_amend http://grants.nih.gov/grants/funding/women__min/guidelines_amended_10_2001.htm ed_10_2001.htm

Collection of Race Information Collection of Race Information

As just noted, Federal oversight agencies As just noted, Federal oversight agencies require require collection of race and gender collection of race and gender information to ensure equality in research. information to ensure equality in research. This should also be taken into account This should also be taken into account when looking at genetics research. when looking at genetics research.

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Principle of Justice Principle of Justice

Much of the federal and ethical impetus for Much of the federal and ethical impetus for including those of different including those of different “ “races races” ” in in research comes from the concept of research comes from the concept of J Justice ustice, as described in , as described in The Common The Common Rule (45 CFR 46) Rule (45 CFR 46) and the and the Belmont Report Belmont Report. .

Principle of Justice Principle of Justice continued continued

Under the Under the Principle of Justice Principle of Justice, the risks as , the risks as well as the benefits are shared equally well as the benefits are shared equally among the participants among the participants – – no one group no one group should be selected to bear a greater should be selected to bear a greater burden or enjoy a greater benefit. burden or enjoy a greater benefit.

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Belmont Report Belmont Report – – Principle of Justice Principle of Justice

According to the According to the Belmont Report: Belmont Report: “ “The selection of research subjects needs to be The selection of research subjects needs to be scrutinized in order to determine whether some scrutinized in order to determine whether some classes (e.g., welfare patients, particular classes (e.g., welfare patients, particular racial racial and ethnic minorities, or persons confined to and ethnic minorities, or persons confined to institutions) are being systematically selected institutions) are being systematically selected simply because of their easy availability, their simply because of their easy availability, their compromised position, or their manipulability, compromised position, or their manipulability, rather than for reasons directly related to the rather than for reasons directly related to the problem being studied. problem being studied.” ” They shouldn They shouldn’ ’t also be systematically excluded. t also be systematically excluded.

http://ohsr.od.nih.gov/guidelines/belmont.html#gob3 http://ohsr.od.nih.gov/guidelines/belmont.html#gob3

IRB IRB “ “Players Players” ”

Principal Investigator Principal Investigator Co Co-

• investigators

investigators Participants Participants Family members Family members Consultants with expertise in Consultants with expertise in racial racial issues issues

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IRB Risk/Benefit factors IRB Risk/Benefit factors

The primary The primary benefits benefits for a participant in a for a participant in a race race-

• based study are generating theories

based study are generating theories about disease risk factors and about disease risk factors and susceptibility to disease. susceptibility to disease. The primary The primary risks risks for a participant in a for a participant in a race race-

• based study are psychological,

based study are psychological, social, possibly physical, and dignitary social, possibly physical, and dignitary harms. harms.

Identification of Risk Factors Identification of Risk Factors for Disease for Disease

The genomics movement has ushered in The genomics movement has ushered in an era where an era where racial racial characteristics are characteristics are paramount in generating theories on risk paramount in generating theories on risk factors for disease. Research can be factors for disease. Research can be instrumental in testing these theories and instrumental in testing these theories and how how racial racial variations impact on the variations impact on the prevalence and course of a disease. prevalence and course of a disease.

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Psychological Risks Psychological Risks

Ramifications of Ramifications of race race-

• based information

based information being disseminated to others. being disseminated to others. Disclosure of sensitive information. Disclosure of sensitive information.

Social Risks Social Risks

Discrimination and stigmatization Discrimination and stigmatization Overlooking true socio Overlooking true socio-

• economic and

economic and environmental factors in the face of environmental factors in the face of race race-

• based research.

based research. Issues for the Issues for the “ “community community” ” members members Disclosure to 3 Disclosure to 3rd

rd parties

parties

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IRB Protections for IRB Protections for Race Race-

• based Research

based Research

The IRB: The IRB: should ensure that there are protections in place should ensure that there are protections in place to warrant against inappropriate disclosures of to warrant against inappropriate disclosures of private information. private information. should understand the risks of disclosure of should understand the risks of disclosure of information. information. must ensure that there is expertise on their must ensure that there is expertise on their Board to review Board to review race race-

• based projects as well as

based projects as well as training and education for all members regarding training and education for all members regarding race race-

• based research.

based research.

IRB General Consent Form IRB General Consent Form Requirements Requirements

The IRB should consider the following The IRB should consider the following when approving a consent form for when approving a consent form for race race-

• based research:

based research: Access to medical records Access to medical records Consequences of withdrawal from the Consequences of withdrawal from the study study Costs associated with the study Costs associated with the study Disclosure of information and the Disclosure of information and the implications of disclosure for participants implications of disclosure for participants

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CASE EXAMPLE #1 CASE EXAMPLE #1 – – The Case The Case

• f the Havasupai Tribe
• f the Havasupai Tribe

The Havasupai are a Native American The Havasupai are a Native American tribe of approximately 650 individuals, 450 tribe of approximately 650 individuals, 450

• f whom live in and around the area of the
• f whom live in and around the area of the

Grand Canyon known as Grand Canyon known as Supai Supai. . The tribe alleges that in 1989, researchers The tribe alleges that in 1989, researchers developed a protocol to study the diabetes developed a protocol to study the diabetes epidemic among the epidemic among the Havasupai Havasupai; however ; however the research protocol was a pretext to do the research protocol was a pretext to do

• ther research.
• ther research.

The Case of the Havasupai The Case of the Havasupai continued continued

The original protocol had 3 aims: The original protocol had 3 aims: diabetes education, collecting blood diabetes education, collecting blood samples, and genetic testing to identify samples, and genetic testing to identify which genes in the Havasupai caused which genes in the Havasupai caused diabetes. diabetes. That protocol was presented to the Tribal That protocol was presented to the Tribal Council in 1989 and 1990 and was Council in 1989 and 1990 and was approved. approved.

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The Case of the Havasupai The Case of the Havasupai continued continued

The Havasupai filed a lawsuit in 2004 The Havasupai filed a lawsuit in 2004 against Arizona State University, the against Arizona State University, the Arizona Board of Regents, and 3 Arizona Board of Regents, and 3 researchers alleging that 400 blood researchers alleging that 400 blood samples from 180 donors were taken and samples from 180 donors were taken and either destroyed, used in studies looking at either destroyed, used in studies looking at schizophrenia, looking at in schizophrenia, looking at in-

• breeding

breeding among the Tribe, and looking at population among the Tribe, and looking at population migration of the Tribe, all without consent. migration of the Tribe, all without consent.

The Case of the Havasupai The Case of the Havasupai continued continued

The Tribe further alleged: The Tribe further alleged:

– – That the researchers improperly obtained That the researchers improperly obtained medical charts on members medical charts on members – – That the IRB did not stop the mishandling of That the IRB did not stop the mishandling of specimens and data specimens and data – – That the Tribe suffered dignitary harm from That the Tribe suffered dignitary harm from the study of their ancestral heritage the study of their ancestral heritage

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CASE EXAMPLE #2 CASE EXAMPLE #2 – – the Case of the Case of Prescribing Prescribing BiDil BiDil

In June, 2005, the FDA approved the drug In June, 2005, the FDA approved the drug BiDil for the treatment of heart failure for BiDil for the treatment of heart failure for self self-

• identified African

identified African-

• American patients.

American patients. This is the first This is the first “ “Race Race-

• based

based” ” medication. medication. BiDil is a combination of two older drugs, BiDil is a combination of two older drugs, used to treat high blood pressure: used to treat high blood pressure: hydralazine hydralazine and and isosorbide isosorbide dinitrate dinitrate. . Neither of these drugs is approved for Neither of these drugs is approved for heart failure. heart failure.

The Case of Prescribing The Case of Prescribing BiDil BiDil continued continued

The original study of a general population The original study of a general population showed showed BiDil BiDil was of no benefit. However, was of no benefit. However, when the African American sample was when the African American sample was examined, there was a significant examined, there was a significant reduction in death when compared to a reduction in death when compared to a placebo. placebo.

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The Case of Prescribing The Case of Prescribing BiDil BiDil continued continued

“ “Today Today’ ’s approval of a drug to treat severe s approval of a drug to treat severe heart failure in self heart failure in self-

• identified black

identified black population is a striking example of how a population is a striking example of how a treatment can benefit some patients even treatment can benefit some patients even if it does not help all patients . . . In the if it does not help all patients . . . In the future, we hope to discover characteristics future, we hope to discover characteristics that identify people of any race who might that identify people of any race who might be helped by BiDil. be helped by BiDil.” ”

• Dr. Robert Temple, FDA Associate Director of
• Dr. Robert Temple, FDA Associate Director of

Medical Policy. (June, 2005) Medical Policy. (June, 2005).

.

“ “Named Populations Named Populations” ”

Diseases often associated with, though Diseases often associated with, though not necessarily always occurring, in not necessarily always occurring, in certain populations with more frequency certain populations with more frequency than others. than others. The IRB should ensure that groups that The IRB should ensure that groups that are are “ “named named” ” are not stigmatized or are not stigmatized or labeled. labeled.

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Classification of Race Classification of Race

Because there is debate as to whether Because there is debate as to whether race race is based on a is based on a sociological sociological construct construct or on a

• r on a biological reality

biological reality, , utilizing utilizing race race as a classification in as a classification in research is a topic of heated discussion. research is a topic of heated discussion.

IRB Review IRB Review

The IRB should be sure that research looking at The IRB should be sure that research looking at “ “race race” ” has a valid design and is scientifically has a valid design and is scientifically sound. sound. The IRB should be ever vigilant to ensure that The IRB should be ever vigilant to ensure that no group is stigmatized or labeled. no group is stigmatized or labeled. The PI should provide justification for the use of The PI should provide justification for the use of race race and do so in a sensitive manner. and do so in a sensitive manner. The IRB should consider the implications of the The IRB should consider the implications of the potential results. Is there some research that potential results. Is there some research that should not be done? should not be done?

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Questions for Questions for Workshop Participants Workshop Participants

Is Is race race a biological reality or a sociological a biological reality or a sociological construct? construct? What should the IRB consider when What should the IRB consider when reviewing reviewing race race-

• based research?

based research? Should an investigator base the Should an investigator base the race race of

• f

participants on their appearance? participants on their appearance? Self Self-

• reporting?

reporting?